Process Analytical Technologies (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters which affect critical quality attributes. The concept aims at understanding the processes by defining their critical process parameters, and accordingly monitoring them in a timely manner thus resulting in a more efficient quality assurance test with reduced over-processing and enhanced consistency.
Various spectroscopic methods currently used in PAT provide a fingerprint by which a molecule can be identified. Near Infra Red spectroscopy (NIRS) which is based on molecular overtone and combination vibrations utilizes the near infrared region of the electromagnetic spectrum to characterize various molecules. Raman spectroscopy relies on inelastic scattering of photons by molecules to study vibrational, rotational and other low-frequency modes in a system.
Several publications discuss the utilization of IR spectroscopy during manufacturing processes.
U.S. Pat. No. 6,395,538 to Naughton R. A. et al. discloses a method and a system for providing real-time, in situ bio-manufacturing process monitoring and control in response to IR spectroscopy.
U.S. Pat. No. 6,853,447 to Goetz A. discloses a method for verifying the contents of a package of materials such as pharmaceutical or food, the method utilizes an array of IR imaging spectrometers.
U.S. Pat. No. 7,126,685 to Paige M. E. et al. discloses a spectroscopy method for characterizing a sample in container such as a pharmaceutical bottle.
DE 19908410 describes a process for testing if an article is authentic characterized in that a tested article is heated up to a predetermined temperature and using a heat radiation sensitive device, the heat emitted from the article is detected and used for determining the authenticity of the article.
DE 19629101 describes a unit for identification, inspection and control of packaging and their content by means of temperature sensitive sensors and IR cameras, used also for spotting and removal of faulty containers.
The FDA's PAT initiative encourages the development of new analytical technologies for constant monitoring of pharmaceutical manufacturing processes.